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Maharashtra - Apply for a Medical Diagnostic Laboratory (Pathology) License

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ProcedureEdit

Apply Online

Step 1: APPLICATION FOR ACCREDITATION

  1. To Apply for a Medical Diagnostic Laboratory (Pathology) License, the applicant has to make their application online via the National Accreditation Board for Testing and Calibration Laboratories portal link
  2. Next, the applicant must click “Register” on NABL accreditation for testing Lab/calibration lab (ISO/IES 17025), Medical Lab (ISO 15189), PTP, and RMP menu.
  3. Enter all the required credentials and click Register.
  4. Next, the applicant must select the service, and fill in all the necessary details in the application.
  5. The applicant has to upload all the necessary documents that are mentioned in the “Required Documents” section of this page.
  6. The application shall be complete in its contents and accompanied by the Management System Document/ Quality Manual, requisite information, and prescribed application fee as detailed in document NABL 100A.
  7. The applicant Conformity Assessment Body (CAB) shall read and understand the terms and conditions for obtaining and maintaining NABL accreditation (as mentioned in document NABL 131) on the web portal and accept.
  8. The CAB shall ensure the correctness of the information provided in the application with special care in filling the scope of accreditation (uploading on the Web Portal).
  9. The CAB shall also submit a “Declaration Form” as provided in the application.
  10. On receipt of a complete application for accreditation, an acknowledgment with a unique ID number shall be provided to the CAB.
  11. The unique ID of the CAB will be used for further correspondence between NABL and CAB. Successful submission of the application on the portal (Initial acknowledgment) is not deemed as acceptance of the application.



Step 2: DOCUMENT REVIEW

  1. The review of documented information submitted by the CAB is carried out by an assessment team (one or more assessors/NABL officers).
  2. The assessment team reviews the documents and submits the report. The names and details of the assessment team members are conveyed to the CAB for identifying any conflict-of-interest issues.
  3. NABL will consider any objection on merits and decide whether to reconstitute the assessment team. NABL decision shall be final and binding in case there is no proven conflict of interest.
  4. The CAB shall review the findings and while taking the corrective actions, the CAB may decide to amend the relevant documents and/or make changes in the management system accordingly within seven days (7 days) to complete the document review process.



Step 3: ASSESSMENT

  1. For any type of assessment, NABL appoints an assessment team which consists of lead assessor/technical assessor(s)/Technical expert(s)/NABL officer(s)/ Observer(s) depending on the type of assessment.
  2. The number of team members depends upon the applied scope for accreditation.
  3. The assessment is generally carried out for two days. It may vary and depends on the applied scope of accreditation, consideration of resources, and facilities available with the CAB w.r.t. applied scope for accreditation. The duration of assessment for CABs applying under integrated assessment is five (05) days.



Step 4: ACCREDITATION DECISION-MAKING

  1. NABL has a system of independent review for accreditation decisions through the accreditation committee. Accreditation decisions are taken by the Sr. Director/ Director, NABL based on the recommendations of the accreditation committee, members of which are different from the assessment team which carried out the assessment.
  2. NABL always ensures that the accreditation decisions are made by competent persons. The Accreditation Committee is provided with adequate information, to enable them to decide on recommendations for grant, renewal, reduction, extension, suspension, or withdrawal of accreditation.



Step 5: ISSUE OF ACCREDITATION CERTIFICATE

  1. NABL issues an accreditation certificate to the accredited CAB which has a unique number and QR Code, field, date of validity along with the scope of accreditation.
  2. This entire process can be completed within 3 to 6 months or as per the timeline advised by the respective department authority.


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Required DocumentsEdit

  • Completed application form
  • Memorandum of association and articles of association of the laboratory
  • Certificate of incorporation from the Registrar of Companies
  • Lease agreement for the premises
  • Certificate of registration with the Chamber of Commerce
  • Curriculum vitae of the staff
  • Proof of ownership of the equipment
  • Proof of financial resources
  • Quality Manual
  • Standard operating procedures (SOPs)
  • Calibration records



Office Locations & ContactsEdit

National Accreditation Board for Testing and Calibration Laboratories
NABL House
Plot No. 45, Sector 44,
Gurugram – 122003, Haryana
Phone: 91-124-4679700 (30 lines); 91-124-4594800/801/802
Fax: 91-124-4679799
Email: [email protected]
(Landmark – Near HUDA City Centre Metro Station, Behind Fortis Hospital)


Bengaluru Office:
1st Floor, Sri Hari Towers 1, 5th A Main Road,
Vinayakanagar, Hebbal, Bengaluru,
Karnataka-560024
Phone: 9910091972, 9884216671, 8076009509, 7204321089, 9810431991


Kolkata Office
Merlin Infinite, Unit No. 1208,
12th Floor, DN-51, Sector-V, Salt Lake City,
Kolkata-700091
Phone: 9871339210, 9999111480, 8744002449, 9540214984
Contact link – link

EligibilityEdit

The requirement of the NABL, the institution (Conformity Assessment Body) must satisfy the following eligibility criteria:

  • The institution must be a CAB carrying out relevant activities such as laboratory testing, calibration, food processing, research, and development.
  • The lab must be located in a suitable premises.
  • The lab must have the necessary equipment and infrastructure.
  • The lab must have qualified and experienced staff.
  • The lab must follow the prescribed standards of quality and safety.


FeesEdit

  • The applicant has to pay the prescribed fee as per the authority’s request.


ValidityEdit

  • The accreditation certificate is valid for 2 years.


Documents to UseEdit

Please attach documents that can be used by people. e.g. links


Sample DocumentsEdit

Please attach sample completed documents that would help other people.


Processing TimeEdit

  • This entire process can be completed within 3 – 6 months or as per the timeline advised by the respective department authority.



Related VideosEdit

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.


InstructionsEdit

  • Applicants must complete the application form before submitting it. Incomplete applications will not be accepted.
  • Applicants must provide genuine information while applying for this procedure.


Required InformationEdit

  • Laboratory Name
  • Mobile No
  • Email Address
  • Fax
  • Zip code
  • Educational Qualifications
  • Technical head/ lab manager
  • Lab details
  • Lab location details
  • No of staff
  • No of instrument
  • Declaration
  • Date
  • Signature


Need for the DocumentEdit

  • A Medical Diagnostic Laboratory (Pathology) License is a license issued by the government to a medical diagnostic laboratory that meets the required standards of quality and safety. The license is required to operate a pathology lab in India.


Information which might helpEdit

BENEFITS OF ACCREDITATION

  • International recognition/ equivalence
  • Access to the Global market
  • Time and money-efficient
  • Enhanced customer confidence and satisfaction
  • Robust Quality Management System
  • Continual improvements
  • Better operational control
  • Assurance of accurate and reliable results
  • Cost Reduction
  • Prevent loss due to defects


Other uses of the Document/CertificateEdit

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.


External LinksEdit

link
link


OthersEdit

  • Accreditation provides formal recognition of competent CABs, thus providing a ready means for customers to find reliable testing (including Medical), calibration, Proficiency Testing and Reference Material Producer services in order to meet their demands. Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. Society also needs to know the technically competent laboratory in fields such as Medical, Forensic, Food Testing etc. The globalization of Indian economy and the liberalization policies initiated by the Government in reducing trade barriers and providing greater thrust to exports makes it imperative for Accredited Laboratories to be at international level of competence.


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